Improved blood glucose control in 5- to 8-year-olds

Action Points

Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.

An artificial pancreas system improved blood glucose control without increasing hypoglycemia in children with type 1 diabetes, according to a randomized cross-over study in 12 patients ages 5 to 8 years.

Note that similar results have been found in large-scale studies of older individuals with type 1 diabetes, suggesting that this type of technology is likely to become the standard of care for type 1 diabetes control for children in this age range.

ORLANDO -- An artificial pancreas system improved blood glucose control in children with type 1 diabetes without increasing hypoglycemia, according to a small study.

In the randomized, cross-over trial, children (ages 5-8 years) with an artificial pancreas (AP) spent more time with his or her blood glucose levels in the normal range (70-180 mg/dL), compared with children with an insulin pump with continuous glucose monitoring (CGM) care at home (AP 73.1%; home 46.9%, P=0.002 after adjustment for level of activity), reported Mark DeBoer, MD, of the University of Virginia in Charlottesville, and colleagues.

Children with an artificial pancreas also experienced lower mean blood glucose (AP 152 mg/dL; home 190, P<0.001 after adjustment for activity), DeBoer said in a presentation at ENDO 2017.

"Our study data show, for the first time, that among young children, 5 to 8 years old, this artificial pancreas maintains blood sugars in the target range better than the usual home regimen," DeBoer said in a press release. "These results, although in a small number in children, show great promise because similar results have been found in large-scale studies of older individuals with type 1 diabetes. In the future, this type of technology is likely to become the standard of care for type 1 diabetes control for children in this age range."

Because many programmed algorithms in AP systems were designed for adults, DeBoer said the goal of the current study was to test the efficacy and safety of using an AP system in young children with type 1 diabetes.

Twelve children participated in the trial. During a 72-hour period of intervention, which took place on a vacation with the participating families and researchers, all children were fitted with a closed-loop AP system. Three days prior and after the "AP camp," the children utilized their usual insulin pump with a CGM (Dexcom G4) at home as a comparison. All children wore FitBit activity trackers to adjust for physical activity differences between the two environments.

The authors reported that the occurrence of hypoglycemia was similar between sessions without differences in time <70mg/dL (AP 6.3%; home 20.8%).

Since each AP was operated through a program on a smart-phone, they had child-resistant, safety lock-out screens with new passwords given daily and exclusively to parents to ensure children would not adjust the settings themselves. No parents reported children discovering the password during the study period, nor achieving access to the system.

DeBoer highlighted that although some parental input of mealtime information is still required with the AP, its able to provide close glucose predictions and subsequent insulin decisions at the right time.

"Up until now, parents and doctors have had to decide how much insulin to give young children throughout the day to avoid dangerously low or high blood sugars," he explained. "Even with an insulin pump, it can be difficult to know how much insulin the child requires because of fluctuations in the carbohydrate content in food, and the child's activity level."

DeBoer said his group saw periods of excitement induced hyperglycemia during the "AP camp" that the system was able to respond to. Additionally with the AP system, there was increased time spent in even tighter target ranges for blood glucose, of 80 to 140 mg/dL.

Studies with a larger patient population are needed as is a protocol with an intervention environment that is similar to the home setting, DeBoer's group noted.

An ENDO attendee asked about the meal bolus, pointing out that it is sometimes difficult to predict when and what children will eat.

During the study, patients were given insulin before a meal, DeBoer responded, adding that the meal may have to supplemented with milk if the child does not eat enough. He also explained that everything was bolused ahead of time during the study and that prior testing of the AP system found that it can make up for some miscalculation, usually for providing more insulin.

Accessibility Statement

At MedPage Today, we are committed to ensuring that individuals with disabilities can access all of the content offered by MedPage Today through our website and other properties. If you are having trouble accessing www.medpagetoday.com, MedPageToday's mobile apps, please email legal@ziffdavis.com for assistance. Please put "ADA Inquiry" in the subject line of your email.